Can digestive enzymes ease Post-Pancreatitis symptoms? new trial aims to find out
NCT ID NCT06477159
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a 6-month course of pancrelipase (CREON) can improve digestive symptoms in people who have exocrine pancreatic insufficiency (EPI) after an acute pancreatitis attack. About 30 adults with confirmed EPI and moderate-to-severe symptoms will take the enzyme replacement and report their symptom changes over time. The goal is to see if this treatment eases discomfort and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients of age 18 or older, able to provide informed consent and follow all study procedures. 2. Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 \< 200 µg/g stool obtained within 3 months prior to baseline assessment (Visit 2). 3. Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2. 4. Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2. 5. Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage). 6. Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase). 7. Women of childbearing potential must have a negative urine pregnancy test at Study Day 1 and practicing at least one protocol specified method of birth control (Section 5.2.4), starting at Study Day 1 through 30 days after last dose of pancrelipase. 8. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile as defined: * Age \> 55 years with no menses for 12 or more months without an alternative medical cause. * Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level \> 40 IU/L. OR * Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). do not require pregnancy testing. Exclusion Criteria: 1. Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled. 2. History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1 3. Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included. 4. Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis. 5. Gastroparesis. 6. Confirmed or suspected cystic tumor associated with main pancreatic duct dilation or believed to be the cause of AP (in the site-PI's judgment). 7. Prior pancreatic surgery or GI tract surgery affecting the upper GI tract including but not limited to gastric bypass surgery, total pancreatectomy. 8. Pregnancy or breast feeding. 9. Patients with life expectancy of less than 6 months due to advanced chronic conditions, such as congestive heart failure or chronic obstructive pulmonary disease, or other conditions which preclude study participation by judgement of the investigator. 10. Incarcerated individuals
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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New York University Langone Medical Center
WITHDRAWNNew York, New York, 10016, United States
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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University of Illinois Chicago
RECRUITINGChicago, Illinois, 60612, United States
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University of Minnesota
NOT_YET_RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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University of Southern California
RECRUITINGLos Angeles, California, 90033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- European registry aims to improve care for pancreatic enzyme deficiency
- CF breakthrough: kids may ditch daily enzyme pills after modulator treatment
- New pill aims to help cystic fibrosis patients digest food
- New MRI study aims to spot pancreas trouble early
- New blood test could spot hidden digestive problems in pancreatitis patients
- Pancreas transplant weight gain mystery: is extra digestive juice to blame?